STA Staclot Protein S, Model/Catalog Number: 00746-Reagent… recallZ-3047-2026 · Diagnostica Stago, Inc. · initiated Jul 29, 2026
Class II Open, Classified All recalls posted in August 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Diagnostica Stago, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
FDA root cause category: Under Investigation by firm
What the company is doing
Diagnostica Stago issued an URGENT: MEDICAL DEVICE RECALL (REMOVAL) notice to its consignees on 7/29/2026 via email. The notice described the issue, risk assessment, and requested the following: "Actions Required To prevent potential workflow disruptions associated with the increased recalibration frequency, we request that you: " Immediately discontinue use of STA-Staclot Protein S, Lot 273074. " Dispose of any remaining inventory of the affected lot in accordance with your facility's procedures and local regulations. " Complete, sign, and return the enclosed Acknowledgement Form by email to confirm receipt and understanding of this notification. Stago will provide a credit for the destroyed kits you indicate on the Acknowledgement Form." For questions regarding this notice or require assistance, please contact Stago's 24/7 Hotline at 1-800-725-0607.
Recall details
- Recall number
- Z-3047-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jul 29, 2026
- Posted by the FDA
- Aug 28, 2026
- Recalling firm
- Diagnostica Stago, Inc.
- Quantity
- 5220 units
- Product code
- GGP
- FDA submissions
- K913424
- Distribution
- US Nationwide distribution in the states and territory of NJ, NY, NJ, VA, PA, FL, AL, GA, TN, OH, IL, MO, NE, TX, CO, UT, CA, PR.
Product description
STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
Code information (models, lots, serial numbers)
UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- STA® - Staclot® Protein S 00746Diagnostica Stago · TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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